Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003240
Protocol/serial number
LU3001
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung (non-small cell) cancer
Intervention
1. Schedule A: Combination chemotherapy, four 3 weekly cycles of mitomycin, ifosfamide and cisplatin (MIC). Followed by radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.
2. Schedule B: Radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.
Intervention type
Drug
Phase
Not Specified
Drug names
Mitomycin, ifosfamide and cisplatin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
01/01/1996
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 75 years or under
2. Histologically or cytologically proven non-small cell lung cancer, ie adeno- squamous or large cell carcinoma
3. Clinically or radiologically evaluable disease 4. Inoperable, but clinically limited stage disease
5. WHO performance status of 0-2
6. No previous chemotherapy or radiotherapy
7. No metastatic disease, except ipsilateral stem cell factor (SCF) lymphadenopathy
8. Normal renal function
9. No other previous or concurrent malignancy, except cone biopsied carcinoma in-situ of the cervix and adequately treated basal cell carcinoma of the skin
10. No pleural effusion or symptomatic superior vena cava obstruction
11. No pre-existing severe impairment of lung function likely to prejudice the safe administration of the proposed radiotherapy
12. No indication that protocol treatment would exacerbate a serious pre-existing medical condition
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
01/01/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 1995 interim analysis in http://www.ncbi.nlm.nih.gov/pubmed/7551939
1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10506617
Publication citations
-
Interim analysis
Cullen MH, Trials with mitomycin, ifosfamide and cisplatin in non-small cell lung cancer., Lung Cancer, 1995, 12 Suppl 1, S95-106.
-
Results
Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL, Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life., J. Clin. Oncol., 1999, 17, 10, 3188-3194.